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AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™

This study has been terminated.
(Business decision of the sponsor)
Sponsor:
Information provided by (Responsible Party):
Agenus, Inc.
ClinicalTrials.gov Identifier:
NCT00058747
First received: April 11, 2003
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

This is a Phase II, exploratory, open-label study of the investigational product AG-858, in patients who are cytogenetically positive after treatment with Gleevec.

The trial will consist of three independent Phase II evaluations of patient groups according to their cytogenetic status as defined in the eligibility criteria (Eligibility Criteria 4a, 4b, and 4c).


Condition Intervention Phase
Leukemia, Myeloid, Chronic
Drug: Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Exploratory Study Of AG-858 Plus Gleevec™ In Patients With Chronic Myelogenous Leukemia (CML) In Chronic Phase Who Are Cytogenetically Positive After Treatment With Gleevec™

Resource links provided by NLM:


Further study details as provided by Agenus, Inc.:

Estimated Enrollment: 40
Study Start Date: March 2003
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Detailed Description:

The goals of this study are to determine the following:

  • To estimate the proportion of patients with a complete cytogenetic response (CCR) within each patient group
  • To estimate the proportion of patients with a substantial molecular response (SMR) within each patient group
  • To evaluate the frequency and severity of adverse events.
  • To assess the feasibility of AG-858 production.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be Philadelphia chromosome positive chronic myelogenous leukemia in first chronic phase
  • Must have a complete hematologic response
  • Must have received Gleevec™, IFN-α, cytarabine, busulfan, hydroxyurea, Homoharringtonine (HHT) or any combination thereof as long as the combination has been discontinued and the dosing of Gleevec™ has been stable for 6 months or greater
  • Must have one of the following cytogenetic statuses:

(A) Less than a CCR after receiving Gleevec™ for at least one year at a minimum dose of 400 mg/day. A stable dose of Gleevec™ must have been maintained for the last six months prior to eligibility testing OR (B) Stable cytogenetic status without CCR (no cytogenic response or progression) in three consecutive determinations over six months while on a stable dose of Gleevec™ (at a minimum of 400mg/day) for at least 6 months OR (C) Cytogenetic progression while on a stable dose of Gleevec™ (at a minimum dose of 400mg/day)for at least 2 consecutive evaluations at least one month apart

  • ECOG performance score of 0 or 1
  • Must be at least 18 years old
  • Not pregnant or breastfeeding and agree to use contraception during the course of the study
  • No prior allogeneic bone marrow transplant or be candidates for curative BMT
  • No immunodeficiency or other serious illness
  • No current use of immunosuppressive medications
  • No other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058747

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, California
La Jolla, California, United States
Los Angeles, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
Farmington, Connecticut, United States
United States, Illinois
Chicago, Illinois, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
New York City, New York, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United Kingdom
Liverpool, United Kingdom
London, United Kingdom
Sponsors and Collaborators
Agenus, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Agenus, Inc.
ClinicalTrials.gov Identifier: NCT00058747     History of Changes
Obsolete Identifiers: NCT00070395
Other Study ID Numbers: C-300-01
Study First Received: April 11, 2003
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Agenus, Inc.:
Granulocytic Leukemia, Chronic
Leukemia, Granulocytic, Chronic
Leukemia, Myelocytic, Chronic
Leukemia, Myelogenous, Chronic
Myelocytic Leukemia, Chronic
Myelogenous Leukemia, Chronic
Myeloid Leukemia, Chronic

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014